Atlas FDA

ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES

FDA 510(k) clearance K031764 · decided 2003-09-05

Clearance details

K-number
K031764
Device name
ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
2003-06-09
Decision date
2003-09-05
Days to decision
88 days
Clearance type
Traditional
Product code
IYE
Device class
2
Regulation number
892.5050
Medical specialty
Radiology
Advisory committee
Radiology
Location
Concord, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, M recall (Z-0168-2016)Siemens Medical Solutions USA, Inc2015-10-27
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, S recall (Z-2812-2015)Siemens Medical Solutions USA, Inc2015-09-24
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, O recall (Z-1059-2015)Siemens Medical Solutions USA, Inc2015-02-05
Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expre recall (Z-0980-2015)Siemens Medical Solutions USA, Inc2015-01-15
Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Ca recall (Z-2174-2014)Siemens Medical Solutions USA, Inc2014-08-10
550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiati recall (Z-1645-2014)Siemens Medical Solutions USA, Inc2014-05-21
Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Syst recall (Z-1663-2013)Siemens Medical Solutions USA, Inc2013-07-03
ONCOR Avant Garde , camera imaging system, Part Number:5863472; Product is manufactured an recall (Z-2642-2011)Siemens Medical Solutions USA, Inc - Radiation Oncology2011-06-23
LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the recall (Z-1970-2011)Siemens Medical Solutions USA, Inc2011-04-13
Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equ recall (Z-1769-2008)Siemens Medical Solutions USA, Inc2008-08-20
Oncor Avante-Garde Medical Linear Accelerator, Material Number: 5857920, with control cons recall (Z-1399-2008)Siemens Medical Solutions USA, Inc2008-04-02
Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle recall (Z-0380-2008)Siemens Medical Solutions USA, Inc2007-12-01
ONCOR Avant Garde,Medical charge-particle radiation therapy system (Medical Digital Linear recall (Z-0164-2008)Siemens Medical Solutions USA, Inc2007-11-09

PMA approvals by this applicant

RecordFirmDate
MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008)Siemens Medical Solutions USA, Inc.2024-09-23
MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007)Siemens Medical Solutions USA, Inc.2020-08-21
MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006)Siemens Medical Solutions USA, Inc.2019-12-10
Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005)Siemens Medical Solutions USA, Inc.2017-09-29
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003)Siemens Medical Solutions USA, Inc.2017-03-23
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001)Siemens Medical Solutions USA, Inc.2016-05-12
MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002)Siemens Medical Solutions USA, Inc.2016-01-13
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011)Siemens Medical Solutions USA, Inc.2015-04-21